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Setid F0a917c7 Bcc9 4860 B0e8 C7592212f40e Applno 21735 Form Cream Vaginal Dosage 0 8 - Drug Product Composition: Terconazole

Terconazole

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

12 API Suppliers, 6 USDMF, 2 CEP/COS, 1 EU WC, 3 NDC API, 6 Listed Suppliers, $ API Reference Price

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

12 FDF Dossiers, 10 FDA Orange Book, 1 Canada, 1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;VAGINAL - 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUPPOSITORY;VAGINAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;VAGINAL - 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;VAGINAL - 0.8%

RELATED EXCIPIENT COMPANIES

3 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 2 Actylis, 8 BASF, 1 Esteem Industries, 1 Finar, 4 Gangwal Chemicals, 1 Nanjing Bold Chemical, 7 Seppic, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

16 Solubilizers, 12 Topical, 7 Parenteral, 7 Emulsifying Agents, 6 Thickeners and Stabilizers, 5 Surfactant & Foaming Agents, 4 Film Formers & Plasticizers, 2 Direct Compression, 1 API Stability Enhancers, 1 Lubricants & Glidants, 1 Granulation, 1 Co-Processed Excipients, 1 Rheology Modifiers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow

1 Data Compilation #PharmaFlow

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 1 Regulatory FDF Prices

MARKET PLACE

6 APIs

6 APIs

REF. STANDARDS & IMPURITIES

2 EDQM, 4 Others

$ Xls

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USFDA APPLICATION NUMBER - 21735 / DOSAGE - CREAM;VAGINAL - 0.8%

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
terconazole(UNII: 0KJ2VE664U) (terconazole - UNII:0KJ2VE664U)	terconazole	8mg in 1

Inactive Ingredients

Ingredient Name	Pharmaderm, A division of Nycomed US Inc.	REMEDYREPACK INC.
Butylated Hydroxyanisole(REK4960K2U)
Cetyl Alcohol(936JST6JCN)
Isopropyl Myristate(0RE8K4LNJS)
POLYSORBATE 60(CAL22UVI4M)
POLYSORBATE 80(6OZP39ZG8H)
PROPYLENE GLYCOL(6DC9Q167V3)
STEARYL ALCOHOL(2KR89I4H1Y)
Water(059QF0KO0R)

Setid F0a917c7 Bcc9 4860 B0e8 C7592212f40e Applno 21735 Form Cream Vaginal Dosage 0 8 - Drug Product Composition: Terconazole

Terconazole

Terconazole

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

12 API Suppliers

6 USDMF

2 CEP/COS

1 EU WC

3 NDC API

6 Listed Suppliers

$ API Reference Price

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

12 FDF Dossiers

10 FDA Orange Book

1 Canada

1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;VAGINAL - 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SUPPOSITORY;VAGINAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;VAGINAL - 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;VAGINAL - 0.8%

RELATED EXCIPIENT COMPANIES

3 Nanjing Well Pharmaceutical

1 Kirsch Pharma

2 Actylis

8 BASF

1 Esteem Industries

1 Finar

4 Gangwal Chemicals

1 Nanjing Bold Chemical

7 Seppic

1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

16 Solubilizers

12 Topical

7 Parenteral

7 Emulsifying Agents

6 Thickeners and Stabilizers

5 Surfactant & Foaming Agents

4 Film Formers & Plasticizers

2 Direct Compression

1 API Stability Enhancers

1 Lubricants & Glidants

1 Granulation

1 Co-Processed Excipients

1 Rheology Modifiers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions

1 Regulatory FDF Prices

MARKET PLACE

6 APIs

REF. STANDARDS & IMPURITIES

2 EDQM

4 Others

Filters

CREAM;VAGINAL - 0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SUPPOSITORY;VAGINAL - 80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CREAM;VAGINAL - 0.8% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons